Jinlida for Diabetes Prevention in Impaired Glucose Tolerance and Multiple Metabolic Abnormalities

This randomized clinical trial investigates whether long-term use of Jinlida granules decreases the incidence of diabetes in participants with impaired glucose tolerance and multiple metabolic abnormalities.

Note: During the study, the mean change and 95% confidence interval (CI) for continuous measurements were calculated using mixed-effects regression models (MMRM).The models were fit to all available data for each measurement.P-values assessed the significance of between-group differences in mean changes, with error bars representing the 95% CI bounds.During the study, the mean change and 95% confidence interval (CI) for continuous measurements were calculated using mixed-effects regression models (MMRM).The models were fit to all available data for each measurement.P-values assessed the significance of between-group differences in mean changes, with error bars representing the 95% CI bounds.Notes: Data are n (%) of the safety analysis population (all randomly allocated participants exposed to at least one dose of intervention) experiencing at least one event.Data are for on-treatment adverse events occurring during treatment.Hepatic disorders are defined as serum transaminase higher than the upper limit of normal value.JLD group: one death due to suicide in patient with depression.The patient was diagnosed with depression 5 months after randomization and hospitalized for treatment many times.One and a half year after randomization, the patient committed suicide.Most common adverse events reported in at least 10% of patients in either group.Events confirmed by event adjudication committee.Benth.

Dosage (Additional material 1)
Take the medicine orally after mixing it with hot water, 1 pack per time, three times a day for 8 weeks as one treatment course, or as advised by health professionals.The use of this product can be combined with western medicine, and appropriate dose reduction of the latter should be adjusted according to the blood glucose level.

Efficacy (Additional material 1)
Actions: To tonify qi, nourish yin, fortify the spleen and transport fluid.
Indications: Type 2 diabetes due to dual deficiency of qi and yin, manifested as thirst, increased water and food intake, increased appetite, increased urination, emaciation, fatigue, lack of strength, spontaneous sweating, night sweating, vexing heat in the chest, palms and soles, and constipation, etc.

Safety (Additional material 2)
Post-marketing monitoring data show that this product may cause gastrointestinal adverse reactions such as diarrhea, nausea, and rash, itching.

eFigure 2 .
Mean changes of blood lipids in the JLD and placebo Note: (A-D) Effect of JLD on Total Cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides.

eFigure 3 .
Mean changes of blood pressure in the JLD and placeboNote: During the study, the mean change and 95% confidence interval (CI) for continuous measurements were calculated using mixed-effects regression models (MMRM).The models were fit to all available data for each measurement.P-values assessed the significance of between-group differences in mean changes, with error bars representing the 95% CI bounds.©2024 Ji H et al.JAMA Internal Medicine.

1 )
The formulation of the research protocol: The clinical research protocol was jointly developed through extensive discussions among clinical experts and statisticians organized by the principal investigators (Fengmei Lian, Xiaolin Tong, Zhenhua Jia).After finalization, the protocol was registered with the China Clinical Trial Registry (www.ChiCTR.org.cn)(ID: ChiCTR1900023241) and published following the commencement of the experiment (doi:10.3389/fendo.2020.00415.Accepted: 26 May 2020; Published: 25 June 2020), ensuring consistency between the actual clinical implementation and the published protocol.Therefore, the objectivity of the clinical protocol's execution was guaranteed, and the possibility of interference in the execution of the protocol was eliminated.2) Randomization Implementation and Statistical Analysis: The randomization protocol, subject Blind, drug Blinding, drug coding, and statistical analyses were all independently conducted by a third-party statistical entity.The implementation of randomization utilized a central randomization system, where both randomization blind codes and drug blind codes were stored.The database was locked, and the statistical analysis plan was finalized before unblinding in the central randomization system.This entire process rigorously ensured the implementation of the clinical trial's randomized double-blind design.3)An independent third-party Contract Research Organization (CRO) is responsible for the organization and implementation of the clinical trial, data collection, and quality control, ensuring the trial's independence, authenticity, accuracy, and completeness.4)This study has formed the Data Safety Monitoring Board (DSMB) and a Clinical Endpoint Adjudication Committee to independently adjudicate safety data and clinical endpoint events (occurrence of diabetes).